To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series.

Secondary Objectives:

To describe in each group the immunogenicity parameters one month after the three-dose primary series.

Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® [ Time Frame: 1 month post last vaccination ] [ Designated as safety issue: No ]

Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.

Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination.

Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® [ Time Frame: Day 150 (1 month post-vaccination 3) ] [ Designated as safety issue: No ]

Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150).

Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® [ Time Frame: Day 150 (1 month post-vaccination 3) ] [ Designated as safety issue: No ]

Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150).

Secondary Outcome Measures:

Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ [ Time Frame: Day 0 up to Day 7 post-vaccination ] [ Designated as safety issue: No ]

Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and PENTAXIM™ injection sites

Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® [ Time Frame: Day 0 up to Day 7 post-vaccination ] [ Designated as safety issue: No ]

Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and ENGERIX B® injection sites.

Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® [ Time Frame: Day 0 up to Day 7 post-vaccination ] [ Designated as safety issue: No ]

Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg

Written informed consent form signed by at least one parent or by another legal representative and an independent witness

Parent/legal representative able to attend scheduled visits and to comply with the trial procedures during the entire duration of the trial.

Exclusion Criteria :

Axillary temperature ≥37.1°C on the day of inclusion

Current or planned enrolment in another clinical trial during the clinical trial period

Known mother's history of Human Immunodeficiency Virus (HIV) infection

Known immunodeficiency (congenital or acquired) or induced by immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or systemic corticosteroids in the last 4 weeks (≥0.5 mg per kilogram and per day equivalent prednisolone and lasting more than 7 days)

History of vaccination against pertussis, tetanus, diphtheria, polio, Hib or HB infections

Vaccination within the last 4 weeks.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00831311